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The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).
The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients treated with afatinib |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| afatinib | Drug | afatinib |
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| Measure | Description | Time Frame |
|---|---|---|
| Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1) | Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported. | From start of afatinib as first line treatment up to 18 months and up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT) | Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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The patients who were treated with afatinib in the first-line setting in each study site after the launch of Giotrif® on 7 May 2014 on a regular basis; their information will be chosen.
Deceased patients fulfilling the eligibility criteria should be enrolled whenever possible.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | 141-6017 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40483538 | Derived | Yamaguchi T, Daga H, Tanaka H, Kijima T, Mizushima M. J-REGISTER: real-world study of Japanese patients with EGFR mutation-positive NSCLC treated with first-line afatinib. Future Oncol. 2025 Jul;21(16):2039-2052. doi: 10.1080/14796694.2025.2514423. Epub 2025 Jun 7. |
| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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Only subjects that met all inclusion and none of the exclusion criteria were included.
Non-interventional, multi-center study from existing data of patients treated with afatinib as the first-line treatment. 40 study sites in Japan were planned for participating. Recruitment of patients was stopped at all sites when it was determined that a sufficient number of patients have been enrolled. A maximum of 50 patients were limited for enrolment per site to avoid differential study site influence on study results. Data extraction started on 01 April 2021 and ended on 07 November 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Treated With Afatinib | Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 4, 2020 | Dec 18, 2024 |
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| From start of afatinib up to 18 months and up to 36 months. |
| Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2) | Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported. | From start of afatinib as second line treatment up to 18 months and up to 36 months. |
| Overall Survival | If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported. | From start of afatinib up to 18 months and up to 36 months. |
| Time to Initial Dose Reduction of Afatinib | Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported. | From start of afatinib up to 18 months and up to 36 months. |
| Percentage of Participants With Dose Modifications of Afatinib | Percentage of participants with dose modifications of afatinib. | From start of data extraction until end of data extraction, up to 586 days. |
| COMPLETED | Participants still on afatinib treatment at end of observation period. |
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| NOT COMPLETED |
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Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With Afatinib | Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1) | Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported. | Final analysis set: All patients who were enrolled in this study and were not excluded due to violations. | Posted | Number | 95% Confidence Interval | Proportion of participants | From start of afatinib as first line treatment up to 18 months and up to 36 months. |
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| Secondary | Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT) | Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported. | Final analysis set: All patients who were enrolled in this study and were not excluded due to violations. | Posted | Number | 95% Confidence Interval | Proportion of participants | From start of afatinib up to 18 months and up to 36 months. |
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| Secondary | Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2) | Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported. | Final analysis set: All patients who were enrolled in this study and were not excluded due to violations. | Posted | Number | 95% Confidence Interval | Proportion of participants | From start of afatinib as second line treatment up to 18 months and up to 36 months. |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival | If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported. | Final analysis set: All patients who were enrolled in this study and were not excluded due to violations. | Posted | Number | 95% Confidence Interval | Proportion of participants | From start of afatinib up to 18 months and up to 36 months. |
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| Secondary | Time to Initial Dose Reduction of Afatinib | Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported. | Participants included in the full analysis set and who had received afatinib at initial dose of 40 mg. | Posted | Number | 95% Confidence Interval | Proportion of participants | From start of afatinib up to 18 months and up to 36 months. |
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| Secondary | Percentage of Participants With Dose Modifications of Afatinib | Percentage of participants with dose modifications of afatinib. | Final analysis set: All patients who were enrolled in this study and were not excluded due to violations. | Posted | Number | Percentage of participants | From start of data extraction until end of data extraction, up to 586 days. |
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Adverse events and deaths were collected for approximately 8.5 years.
Final analysis set: All patients who were enrolled in this study and were not excluded due to violations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients Treated With Afatinib | Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®). | 486 | 805 | 8 | 805 | 43 | 805 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 26.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
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Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2022 | Oct 11, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Non-Asian |
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